drugset / Trial / NCT04311489
Refractory Ascites in Patients With Liver Cirrhosis, and the Potential Treatment With 48 Hours Infusion of Ularitide.
Phase 2
Terminated
17 enrolled
University of Aarhus
ADS AIPHIA Development Services AG · collabAarhus University Hospital · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This clinical trial intends to investigate the safety, tolerability and efficacy of ularitide on the renal response in patients with liver cirrhosis and refractory ascites for a maximum exposure duration of 48 hours, through a randomized, placebo-controlled, double-blind, single-center trial.
Timeline
- Start
- 2020-08-01
- Primary completion
- 2022-11-30
- Completion
- 2022-11-30
Publications
- Background Carstens J, Greisen J, Jensen KT, Vilstrup H, Pedersen EB. Renal effects of a urodilatin infusion in patients with liver cirrhosis, with and without ascites. J Am Soc Nephrol. 1998 Aug;9(8):1489-98. doi: 10.1681/ASN.V981489.
- Background Carstens J, Gronbaek H, Larsen HK, Pedersen EB, Vilstrup H. Effects of urodilatin on natriuresis in cirrhosis patients with sodium retention. BMC Gastroenterol. 2007 Jan 26;7:1. doi: 10.1186/1471-230X-7-1.
- Background Gantzel RH, Meyer M, Mazgareanu S, Aagaard NK, Jepsen P, Holzmeister J, Watson H, Gronbaek H. Ularitide as treatment of refractory ascites in cirrhosis- a study protocol for a randomised trial. Dan Med J. 2021 Nov 12;68(12):A07210610.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ularitide | Protein / enzyme biologic | 15 unknown | Intravenous |
| Subject | Ularitide | Protein / enzyme biologic | 30 unknown | Intravenous |
| Subject | Ularitide | Protein / enzyme biologic | 45 unknown | Intravenous |